GE Healthcare Recalls Infant Resuscitation T-Piece Upgrade Kits
GE Healthcare is recalling 561 infant resuscitation T-piece upgrade kits because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate gas mixture) to a vulnerable population (infants) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
GE Healthcare is recalling 561 units of the Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226, and M1223628. These devices provide the basic equipment required for pulmonary resuscitation of infants.
The recall was initiated because the medical device adjustment knob may be loose, which can affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
The affected units were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international locations. Healthcare facilities and consumers should check their inventory for the specific part numbers and serial numbers listed in the official recall notice.
The recalled product
- Product
- Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
- Manufacturer
- GE Healthcare
- Affected units
- 561
Distribution
Part of a larger recall action
This product is one of 6 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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